BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASKU

    MDR report key: 1991672 · Received February 15, 2011

    Report

    Report Number
    2183613-2011-00020
    Event Type
    Injury
    Date Received
    February 15, 2011
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S72
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT. THE BATTERY RELEASE, BATTERY DRAWER, BATTERY DRAWER O-RING, AND BATTERY FLEX WERE CONTAMINATED, AND THE BATTERY CONTACTS WERE COMPRESSED. ONE SIDE BAIL WAS MISSING, AND THE UPPER CASE, LOWER CASE, AND TWO SIDE BAIL COVERS WERE BROKEN.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE MALFUNCTIONED, AND THE PATIENT WENT ASYSTOLIC. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE MALFUNCTIONED, AND THE PATIENT WENT ASYSTOLIC. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASKU EXTERNAL PULSE GENERATOR DTE MEDTRONIC MILACA INC. 5388 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| O